Datascope recalls MEGA 7.5Fr IAB catheters due to risk of introducer dilator fracture during insertion, potentially causing arterial damage or embolization. 10 complaints including 3 serious events and 1 death reported.
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Datascope is recalling its MEGA 7.5Fr IAB catheters because the introducer dilator can fracture during insertion, risking damage to blood vessels or embolization. This could lead to surgery or delayed treatment. The recall includes multiple model variants sold globally.
During catheter insertion, the introducer dilator may fracture at the hub, leaving the body inside the sheath. This can damage the femoral artery, descending aorta, or cause embolization. It may also require surgery or delay life-saving therapy.
Patients receiving this catheter for counterpulsation therapy in the aorta. Those with the specific model numbers listed in the recall are most at risk.
Check for model numbers starting with 'MEGA 7.5Fr' and part numbers like D684-00-0295-01 to D684-00-0295-10 or D684-00-0294-01 to D684-00-0294-10. The product was sold globally with variations for different regions.
Discontinue use of the recalled catheter as it poses a risk of serious injury during insertion.
The introducer dilator can fracture during insertion, potentially causing damage to blood vessels or embolization, which may require surgery or delay life-saving therapy.
The recall includes multiple model variants sold globally, with specific part numbers listed in the product description.
The recall record does not mention a replacement or remedy.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2219-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2219-2023 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
